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Medicare Coverage Policy ~ Decisions
Noninvasive Positive Pressure RADs for COPD Patients
(#CAG-00052)
Tracking Sheet
| Issue |
HCFA is reviewing the use of (RAD) for severe chronic
obstructive pulmonary disease (COPD) patients to determine if
these devices for COPD patients meet the reasonable and
necessary provision at section §1862(a)(1)(A) of the Medicare
statute. |
| Background |
We have received inquiries from manufacturers, clinicians,
and professional associations and groups, expressing concerns
and requests for changes in the regional medical review policy
(RMRP) for RAD used for category II patients with severe COPD.
The National Association for Medical Directors of Respiratory
Care hosted a multi-disciplinary consensus conference
addressing specific applications for RAD in February 1998. The
RMRP adopts all of the recommendations of the consensus
conference, with exception of one. The recommendation not
adopted concerns use of the device for severe chronic
obstructive pulmonary disease (COPD) patients.
The RMRP for RAD is divided into four categories: (1.)
restrictive thoraic disorders, e.g., neuromuscular disorders
such as amyotrophic lateral sclerosis, (2.) severe chronic
obstructive pulmonary disease (COPD), (3.) Central sleep
apnea, i.e., apnea not due to airway obstruction, and (4.)
obstructive sleep apnea (OSA). The RMRP for RAD used for COPD
patients requires among other things, a facility-based
polysonogram to rule out obstructive sleep apnea in order to
initiate Medicare coverage, with a prerequisite trial of
noninvasive ventilation without a backup rate and treatment
with continuous positive airway pressure devices. We have been
asked to review the RMRP for RAD for COPD patients and we will
review entire RAD policy with the intent to make a national
coverage decision. |
| Benefit Category |
§1861(n) Durable Medical Equipment |
| Requestor(s) Name |
HCFA Coverage and Analysis Group |
| Date of Request |
February 7, 2000 |
| Current Due Date |
November 4, 2000 |
| Lead Analyst(s) |
Francina C.
Spencer
(410) 786-4614 |
| Actions Taken |
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| February 17, 2000 |
Intent to review current policy regarding use of RAD in
COPD applications and if necessary develop a national coverage
policy posted on HCFA website. |
| April 25, 2000 |
Met
with representatives of the Coalition of Respiratory Care
Manufacturers and the American Association for Homecare. They
requested that the scope of this review be more narrowly
defined to include "a small subgroup of very severely ill COPD
patients, who require RAD with backup rate."
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| May 7, 2000 |
Due date revised. HCFA has extended its original date to
August 7, 2000 to accomodate a requested change in focus of
the review to a narrower subgroup of very severely ill COPD
patients who require RAD with backup rate in the home setting
and should not be subject to a trial on a RAD without backup.
Requesters suggest this subgroup of patients are those who
have recently been discharged from prolonged hospitalization
during which RAD with backup rate was required for an extended
period and now need to continue use of RAD in the home
setting. While we are continuing to analyze this coverage
issue, we are requesting evidence that supports the use of RAD
devices for this subgroup of very severely ill COPD patients,
identifies the population, and establishes the criteria to be
used for this population of COPD patients when these devices
are used in the home. |
| August 4, 2000 |
Received two articles as evidence to support use of the
ventilator with backup rate for severely ill COPD patients
during this period and revised due date for coverage decision
to November 4, 2000, to adequately consider the
evidence. |
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